Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING Back to Search Results
Model Number 24653
Device Problems Difficult or Delayed Positioning (1157); Difficult or Delayed Activation (2577); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/20/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Device is combination product.
 
Event Description
It was reported that a stent deformation occurred.Vascular access was obtained via contralateral approach.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery (sfa).A 6x120,130 cm eluvia drug-eluting vascular stent system was selected for use.The lesion was predilated.There were no kinks noted in the catheter.The dial of the device was rotated and deployment was performed; however following the rotation of the dial, 10% of the stent was not developed.The dial was spinning idle and after waiting for 5 minutes, the device deployed naturally; however there was a possibility that the stent might be stretched if the catheter was pulled.There was no stent fracture noted.There were no patient complications reported.
 
Manufacturer Narrative
E1: state/province: kumamoto prefecture.Device is combination product.Device evaluate by mfr: returned product consisted of an eluvia self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the sheath was kinked and partially separated at the nosecone.There was a kink to the inner liner 13.8cm from the tip.Microscopic examination revealed damage to the tip.Inspection of the remainder of the device, revealed no other damage or irregularities.
 
Event Description
It was reported that a stent deformation occurred.Vascular access was obtained via contralateral approach.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery (sfa).A 6x120,130 cm eluvia drug-eluting vascular stent system was selected for use.The lesion was predilated.There were no kinks noted in the catheter.The dial of the device was rotated and deployment was performed; however following the rotation of the dial, 10% of the stent was not developed.The dial was spinning idle and after waiting for 5 minutes, the device deployed naturally; however there was a possibility that the stent might be stretched if the catheter was pulled.There was no stent fracture noted.There were no patient complications reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10047613
MDR Text Key190662991
Report Number2134265-2020-06286
Device Sequence Number1
Product Code NIU
Combination Product (y/n)N
PMA/PMN Number
P180011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 07/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/03/2021
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0024535826
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2020
Date Manufacturer Received06/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDEWIRE: 0.014INCH JUPITER; GUIDEWIRE: 0.014INCH JUPITER; INTRODUCER SHEATH: 6F DESTINATION; INTRODUCER SHEATH: 6F DESTINATION; GUIDEWIRE: 0.014INCH JUPITER; INTRODUCER SHEATH: 6F DESTINATION
-
-